...Thank you. We'll continue with the next session. I'm Paul Choi, and I cover Goldman Sachs Biotechnology here at the firm. It's my pleasure to welcome UroGen to this session. To my immediate left is Liz, CEO, and at the far end is Mark, CMO. What I'll do is maybe give Liz a minute or two to maybe do some introductory remarks, and then we'll get into Q&A.
Sure.
We'll do that? Okay.
Yeah, that would be great. First of all, I just wanna say thank you for having us here. Always a pleasure to be here. Very excited about UroGen and the place that we are in our company's history. It's a real pivotal year for us. I think a lot of people know that we're awaiting some data later this week, so it's a big week for us. Our company was really founded on the idea that patients with urothelial cancers deserve better. We developed a technology called RTGel technology, which allows for medicines to dwell longer in the cavity. So we're really happy that we have one medicine on the market today called Jelmyto, and anxiously awaiting our second medicine, UGN-102, for low-grade intermediate-risk non-muscle invasive bladder cancer.
I'm happy to be here, and again, thank you for having us. Thrilled to have Mark with us. I always blame him for the reason that I joined the company, because when he talked about the high unmet need in this space, but Mark, maybe just introduce yourself would be great.
Thank you, and thanks again for the invitation. Great to be here. Mark Schoenberg, Chief Medical Officer of UroGen. I've been with the company for 10 years, since even before our first drug was approved. I specialize in taking care of patients in my other job, patients who have urothelial carcinoma. The mission of UroGen and the drugs we're bringing to help patients are very dear to my heart, so very nice to be here and looking forward to the conversation.
Okay, great. Liz, you actually sort of touched on my first question here, which is, you know, people are focused on bladder cancer and urothelial cancer, but really, I think at your core, UroGen is sort of a platform company.
Yes.
You have this central technology, which you could theoretically leverage into multiple areas beyond oncology, but just maybe if you could maybe just explain sort of the origins of UroGen and just how the RTGel technology formula was developed and just how you initially developed it in Jelmyto.
Yeah, sure. And it's, it's really important to understand how urologists treat urothelial cancers, right? And they treat them locally, so very different than oncologists and others, other cancer settings. Urothelial cancers, you know, really get treated locally with local medicines. The problem is, because of the urinary canal, it just gets voided out very quickly. And so these urologists in Israel, and our company was founded in Israel, said, "Wouldn't it be great if we could figure out a way for medicines to stay longer?" And that is basically what happened, right? And these chemists went about developing the RTG el, reversed thermal gel, because it's actually liquid when it's cold. It gets mixed with an active, and we've actually demonstrated with our technology that there's pretty much not... You know, we've been able to mix pretty much all types of different therapies with it.
So we can do small molecules, we can do large molecules. We believe we can put a vaccine, we believe, you know, IO agents in our CTLA-4. So we have a lot of opportunity to really advance the way that these cancers are treated, and to your point, not just for urothelial cancers, but other diseases in urology, but then also other adjacent cancers, like rectal cancer as an example. So we believe that the technology has a lot of broad utility. We've been focused on urothelial cancers, but, you know, when we think about our company and building a long-term growth company, we absolutely wanna look at more products in connection with our technology, as well as moving it into other areas.
Okay, great. And for people who are new to the story, people forget your chair is Arie Belldegrun, a legend in the biotech community here. So, your first application of RTG el has been obviously for your approved commercial stage product, Jelmyto, which is approved for upper tract. And can you maybe talk a little bit about, you know, how the launch experience has been? You've launched a few years ago.
Yes.
It's a small opportunity versus, you know, some of the things that are ahead of you, but can you maybe describe the commercial progress to date and just sort of the trends you're seeing in terms of recent Jelmyto commercial performance?
Yeah, absolutely. And, Jelmyto is for upper tract urothelial carcinoma, and again, low- grade upper tract urothelial carcinoma. But the reason I sort of put you know emphasis on the low- grade is these patients, so first of all, the median age is 74, and because either you can't reach the tumor or you're not able to ablate it or it comes back, these patients were losing their kidney. And when you think about you know kidney function, we know that age is a driver of reduced kidney function. So even though you can live with one kidney, you don't really want to if you don't have to. So the idea of being able to actually treat these medicines and be able to maintain the kidney was a big driver in the success of Jelmyto.
So we launched Jelmyto actually in 2020, right into the head of, of the pandemic. So we weren't able to actually have an in-person launch. We did everything virtually. It has continued to grow. We have about a 12% penetration today. It was not as fast as we expected. Part of that was driven by the pandemic, but also part of it is driven by the fact that there's only 6,000 patients who have this every year, and you've got 6,000 urologists, right? So it's not a situation where in a rare disease, you can go to the top 20 institutions-
Yeah
... and they treat all the patients, right?
It's not a concentrated market.
It's not. It's a mile wide and inch deep, and really finding these patients has probably been one of the biggest challenges, but the good news is we have what we call patient enrollment forms. So for every patient, we've hit records on our patient enrollment forms in Q1 of this year. We've continued to see double-digit growth year-over-year, and we expect to continue that. We've sort of, you know, guided to $200 million-$300 million peak revenue, but it's a slow, steady growth, and that's what we've seen. Introducing new sites of care so that wherever that patient goes, that we're there, is really important to our continued success.
Could you maybe elaborate, Liz, a little bit on the tweaks you've done since the launch to, you know, to further implement, you know, penetration? You talked about relatively low market penetration relative to the opportunity set, but you're commercializing annualizing at, you know, roughly half your peak sales potential-
Yes.
roughly, give or take here.
Sure, sure.
Just kind of, you know, what you've done and what you think you might need to do to further drive adoption here and awareness.
Yeah, I think the number one thing is around generation of data. When we launched, we launched on one single-arm study, 70 patients. But since then, and actually recently at the AUA, and I'll ask Mark to talk about the data that was presented, we've gotten a lot more data. And actually, the experience that physicians and patients are having post the clinical study has actually is even better than what we've seen in the clinical study. But Mark, maybe just talk about the increasing data that we've we have-
Yeah.
-for Jelmyto.
One of the really nice developments in the world of Jelmyto has been the generation of real-world data as more and more practitioners have become familiar with the asset. What we've learned, and some of this was actually presented at the May American Urological Association meeting, was that maintenance therapy appears to be beneficial. We now have very concrete evidence, although it's a small group of patients, that maintenance therapy, which was available in the original clinical trial but not used by all investigators, is a real benefit to patients. Also, the durability of response turns out to be exceedingly long. Patients who achieve a complete response after surgery typically relapse within about six to 12 months. In the Jelmyto population, if you get a complete response, you can be disease-free for more than four years.
So these are really sort of incredible data in the context of the contemporary treatment of this population. And then finally, it's becoming clearer that since Jelmyto can be delivered, as it was in the clinical trial, in a retrograde fashion, with a catheter passed through the bladder up into the kidney or through a tube passed directly through the back by a radiologist into the kidney, which is called a nephrostomy tube. The adoption of both methods seems to be getting traction in the community, and there was a very nice video by investigators at the University of Michigan detailing the exact steps involved. So people are becoming more and more comfortable with the variety of ways you can deliver this medication in practice.
Okay, great. I don't want to steal your thunder because you obviously have an event coming up later this week. But, you know, I think, you know, the regular pattern we've seen in among biotech investors is when there's a catalyst or a data set coming up, the interest in the stock and the company, obviously it goes up exponentially versus, you know, companies that don't have updates or catalysts coming up. So, and in your case, it's the twelve-month durability data from the ENVISION study. Can you maybe just, you know, first remind us, you know, sort of how to think of, you know, what is this data set? How much of, you know, data will you disclose, and sort of what do data mechanics look like?
Maybe we'll start there just in terms of the process and mechanics, and then just sort of understanding the sort of clinical expectations.
Sure.
So I guess I can't say no comment. Well, thanks for the question. This is very exciting for us. The ENVISION trial is the pivotal trial that will complete our clinical data package for submission of our NDA for UGN-102, which we expect to submit in September of this year. And we're very excited because, as we announced last year, in a very large study, 240 patients who received UGN-102 for the treatment of recurrent low-grade intermediate-risk disease, the complete response rate was essentially 80%. It's a very high clinical response rate for this group of patients.
So now we have the privilege, because we've really committed to the FDA to do this, to present data on durability response with a minimum of 12 months follow-up from that initial evaluation time point, which, as you will remember now, is 15 months into this trial. So a very robust durability data set. So we're excited to offer those data on Thursday and hope everyone will tune in to the webcast. We'll have safety data as well. And just to remind everybody, this is the culmination of a long clinical development program that included a phase II program called OPTIMA II, and then ATLAS, which is a randomized trial against the standard of care, which is transurethral resection of the bladder tumor.
In those two predicate trials, new and recurrent patients were treated, so we have a robust data set that includes patients with de novo disease, recurrent disease, but remember that the ENVISION trial is focused on recurrent disease.
Okay. So it, it is, again, a treatment-experienced population. And again, maybe just to ... In terms of minimum follow-up for this population, correct?
Time that patients were evaluated to 15 months.
Only in recurrent population?
Yeah, ENVISION is a recurrent population, yes.
Great. So maybe before we get into sort of data and thinking about durability response here, can you maybe remind us just in terms of the patient population and the demographics, and how does this patient population compare relative to the one you're currently tackling or addressing with Jelmyto?
Right. So with Jelmyto, it's the upper tract urothelial carcinoma, and here it's actually bladder cancer. And, what, you know, what's interesting about is when we talk about the complexities associated with delivering Jelmyto, which has been one of the challenges, it's actually much easier with bladder, and it's mainly geography or anatomy, right? So you don't have to manipulate the upper tract. It's very simple to access the bladder. And, but they're very similar in the sense of they both use our RTGel and they use mitomycin, but it's tissue in a different volume because the bladder is much bigger. So we expect it, even though the disease is very similar from a genetic and molecular makeup, so we expected to see very similar results. And I think one of the things that I can say about our clinical experience, it's been very consistent.
We've seen very consistent data, both in our clinical studies, in real world use, in Jelmyto, with Jelmyto in the upper tract and with the UGN-102 in the bladder. And so that gives us a lot of confidence about what we'll see going forward and how these medicines will impact patients, you know, in the real world. So we're excited to bring a very similar but yet different product. And the main big, other big difference is you've got 6,000 patients in the upper tract, you've got 82,000 patients in bladder. And why that makes such a difference from a commercial standpoint is finding these patients is so much easier. Every urologist sees bladder cancer patients.
Every urologist sees these low-grade bladder cancer patients, and every urologist know that they have these patients that they consider to be frequent flyers, those that typically recur and those that are intermediate risk. And so physicians have experience with those patients and are, you know, interested in seeing UGN-102 ... to provide a new therapy option for these patients who are going through these repetitive surgeries right now.
Okay. Just to remind us, Liz, that 82,000 is inclusive of all grades and various treatment paradigms, whether it's post BCG or intermediate or higher risk, or is that just the low- grade?
Actually, no, that's ... It is both de novo and newly diagnosed, as well ... 20,000 of the 80,000 has been newly diagnosed. So every year, about 20,000 are newly diagnosed, and about 60,000 recur every year. So they come from the recurrent pool. You know, Mark talked earlier about the fact that ENVISION is just the recurrent patient population. We believe that the bigger, majority of the opportunity for UGN-102 is in the recurrent patient population, because these patients have gone through a TURBT, and then they come back, at point they recur, and they'll see UGN-102. But no, that is just the, our targeted. You actually look at bladder cancer, there's over 700,000 people living with bladder cancer in the United States alone.
Great. Mark, maybe coming back to you, you on your most recent earnings call, recently talked a little bit about the ATLAS data and just reference that as a potential proxy for ENVISION. Remind us that there are obviously some major differences in terms of both the population and studying in ATLAS versus ENVISION. But just how should we think about ATLAS as potentially being representative for the outcome here with regard to durability in terms of the like-for-like population?
Sure. Thank you. So, Alex, there is a subpopulation in ATLAS of patients who had recurrent disease when they entered the trial. In a manner that is completely analogous to the ENVISION population, these patients had, on average, about two prior surgical procedures. That's also consistent with our experience in the ENVISION population. So they look from the get-go, like the ENVISION patients we've enrolled, and their experience, we think, is reflective of what to expect of the durability from the ENVISION population. In that recurrent subset in ATLAS, the durability of response at 12 months was 66%. So we are expecting that the durability in ENVISION for the entire population, because it's entirely recurrent, would somewhat mirror the ATLAS experience as well.
Okay, great. One of the things I think that investors also are diligencing at the moment is just what does it mean for your typical, to the degree there is a typical practicing urologist in this field? What does something like that, data in the mid-60s% type range mean? What is the clinical meaningfulness of that, and just, you know, how does I guess, as you speak to KOLs and physician practitioners, how does that sort of number resonate versus some of the benchmarks that are out there for TURBT?
Go ahead. Dr. Schoenberg.
Yeah, you know, I think what we've learned from talking to KOLs, and I'll speak also from my personal experience, this is an older population of patients whom we are all, as physicians, well aware are ill-served by repetitive surgical intervention. There's a variety of morbidities associated with TURBT that are, that's very familiar to urologists. In addition to an emerging set of information about the morbidity of repetitive anesthesia in this population, which actually can contribute to cognitive decline over time. So we know about the morbidity of the standard of care. Here we are offering both physicians and patients the opportunity for an in-office, non-operative alternative to repetitive surgery for a group of patients who have a very minor risk of disease worsening over their lifetime.
So here, because the goal is to both treat the disease and then forestall recurrence, we have what we think is a very cogent alternative to the standard of care, which we think will be appealing not only to physicians who are familiar with the procedure and its downsides, but also the patients, who, as we talk to more patients, and we are doing that, inform us that, while surgeons think this is a relatively minor procedure, patients don't, and Liz may want to actually-
A couple of comments. One, we actually did a questionnaire in the ENVISION study, specifically because we wanted to get feedback from patients... and over 90% of patients preferred. And these are patients that had already had a prior TURBT at one point, and they overwhelmingly preferred UGN-102, and a lot of it was driven by the fact, is what Mark said, that they could go on about their daily lives. And, so they didn't have the type of bleeding, and they could, you know, leave their appointment and stop at the grocery store on their way home, versus if they had a TURBT, they were home, they were in bed. There was a week, you know, weeks of time, and we'll see some of that at our event on Thursday.
We actually have a patient who was in our study, is going to be there, and I'll get to talk to him. But we also have, a physician from UNC who will talk about the data from, from patients. So we're excited about that. And I think for physicians want this as an alternative, and Mark, correct me if, if, if you disagree, but the data that they've seen so far is actually much better than they expected. I think it's better than we expected. It's better than the physicians expected, and so they actually, their bar was even lower than ours. You know, we've always said for years, as we've been talking, you know, 50% and 50% of them are still in response at 12 months. That's meaningful.
Physicians have said even lower than that, but then our data has shown that it's actually more, it's better than that. So, you know, with that robustness of all of the data that we have, you know, in connection with that, and physicians have said, "Look, in the beginning, I'm gonna use it in 3..." You know, they have low-hanging fruit. "I'm gonna use it in 3 patient populations." We know from SEER data, 23% of patients have 5 or more recurrences. They have what they call early recurs, and they, you know, are estimating about 25% of their patients early recur. So they come back at their 3-month, 6-month, 9-month visit, and they've already recurred. And there's a group of patients, as Mark talked about earlier, that really should not be going through surgery.
For those patients, when you put those three buckets together, physicians have told us, "That's who I'll try UGN-102 on first." Then I think from there, they'll expand it, assuming they get a positive experience. We also believe that engaging the patient, especially after the feedback we got from the study, that we would want to do that, and the patient will have a voice in that decision as well.
Okay. And again, maybe just to remind the audience, this is 12-month data in a responder population, not the entire-
Correct.
- ITT population.
Correct.
Okay, very good.
Yes.
So, you know, knock on wood, you know, the data holds up here, and you can advance to the regulatory stage. You talked about filing, you know, basically by the end of next quarter, completing your filing here. And so maybe sort of if the data is consistent with Atlas, you know, how do you, you know, think about what the timeline post an acceptance of filing might look like? You had a priority review for Jelmyto. Does you know, does something like this, I guess, in your mind, potentially support a similar priority review here, or should we think about more of a regular re-review cycle?
Mark, do you want to talk about the timing?
Sure. So we'll submit, as I said, in September, and we will apply rather for priority review, and we're hopeful that we'll get it based on the strength of our data. And assuming that, and we've actually been told that we will be taken to an ODAC because this is paradigm-changing therapy. And it's not, I think, a criticism of what we're doing, it's simply a way of having the FDA get some comfort from the community that this is both an acceptable and actually a desirable alternative to the standard of care.
Okay.
So we look forward to that ODAC actually talking about our therapy. And then I think if granted priority review and a successful application and approval by the FDA, then we would launch at the end of Q1.
Okay, great. I guess another question is, you know, since you brought up the ODAC and just thinking about, you know, changing, you know, hearts and minds of a community that's been used to TURBT for a couple generations now, I guess, in terms of training of urologists, I guess, what data as you think that might come up in an ODAC versus historic are sort of key in your mind?
Yeah. Yeah.
Yeah. I mean, I think the safety profile will obviously be key to that conversation. And when I say safety, I'm not simply talking about local symptoms or the things that bother patients, but also things that concern physicians and particularly oncologists, mainly concerns about the forward progression of disease. You know, what % of the people who had UGN-102 got into trouble? Now, we know, thankfully, that particularly because of the population we're working on, the likelihood of developing worsening disease is low, and the likelihood of developing stage migration to actually invasive cancer is incredibly low. So we're not expecting to see those type of safety signals, but we will certainly be asked about that.
Based on what we know from our predicate experience, we're pretty confident that we'll be able to answer that in a very affirmative and reassuring way, both to the FDA and the ODAC.
Okay, great. I'm sure you guys will do lots of practice or mock ODACs-
Yes, we will.
over fourth quarter and first quarter of this.
Planning has already started.
Great. Okay, maybe question looking forward, you know, hoping for approval next year and launch, you know, how you think about where your commercial footprint is in terms of your sales force and marketing spend, you know, potentially for UGN-102 launch, and, you know, how can you leverage the existing infrastructure in terms of existing sales call points versus what you may need to do in terms of additive increases to the sales force?
Yeah, the great news is that it has about a 95% overlap. So, you know, those physicians, as I mentioned before, all of these patients really treat the UTUC patient, and they treat the bladder cancer patient. Having said that, we have about 42 reps today, and we're going to go to 60. A lot of that driven, frankly, by geography. For you, you need to reach in frequency, you need to reach these physicians on an ongoing basis. So we'll move, we'll add a region, you know, to our current organization, and we'll have like one to two field reimbursement manager, a clinical nurse educator, and so the support staff to go along with those. But so again, we expect to have about 60 reps, you know, about eight regions....
Across the country, and we believe that we will be able to capture 80%-90% of patient population.
Okay, great. Maybe also looking a little further ahead in terms of the beyond, on the commercial side, talking a little bit about coverage and establishment of J-codes as needed and so forth like that.
Yes.
You obviously have some experience with that, with Jelmyto. Maybe just in broad strokes, how do you think about the cadence of that sort of developing over time, post and approval, and just sort of what sort of the major landmarks would be in terms of getting payer coverage in what is largely a Medicare age population?
Yeah, no, it's a great question, and the good news is, is that when you get an approval, Medicare does cover medicines that get FDA approval. But you are right, in the beginning, for the first 6 months, we'll have a miscellaneous code, and that does cause some pause for physicians, particularly in the community practice. So much like we saw in Jelmyto, we expected in the beginning, more institutions would use it because they don't worry about reimbursement as much. In the institution, they actually can get reimbursement sooner. They'll get a C code versus a J code, but it takes, again, about 6 months. We're actually very fortunate now because used to, they only looked at J codes once a year. Now they actually do them every quarter, so we should for the first 6 months. So you're right.
In the beginning, we expect until we get that J-code, it should be a little bit slower, be more toward the institutions. But then we really expect that this is a community-driven medicine, right? Because Mark said before, it can be done in the doctor's office. It doesn't even need to be done by a physician. It can be done by an extender. So, you know, one of the first things we'll do as soon as we get EOBs or explanation of benefits, you know, we take out the patient identification information and really show the practices that they can get reimbursed. We also have other programs in place. We have extended dating that we provide. We actually have a very generous return policy.
So if the drug gets delivered and for some reason the patient can't show up, you know, they're not out that amount of money because obviously that's very concerning. Having said that, the practice economics for the practice is actually very positive. So if you think about it from a perspective of being able to, again, see these patients in the office, they'll get reimbursed for their CPT code, for the instillation, for the visit, and for the drug, right? So it's a buy- and- bill drug. They just have to get over that initial hump and get to the point where we have a permanent J code.
Okay, great. I want to talk maybe just briefly, and you and I have had conversations on this before, is just, you know, where your current thoughts are in terms of product profile relative to, to Jelmyto. You know, for those of you who are unfamiliar with Jelmyto, there is some mixing involved-
Yes.
At least with the initial, you know, product profile, and just, you know, what you can do in terms of make the physician and office experience, you know, the easiest, easy as possible, and just how you think about the product profile. Do you want a pre-mixed drug? The whole setup is ready to go, and you just unwrap it and deliver the therapy. Just kind of, you know, where's the current product profile?
No, absolutely.
Shelf life and things like that.
Sure. No, great. As you know, when we launched Jelmyto, that was the other challenge. We- you actually only had eight hours from the time the drug was mixed to the time it needed to be instilled into the patient. For, and then we were able to get it up to 96 hours for Jelmyto after a couple of years on the market. Actually, we will be launching UGN-102 with seven days, so there won't be, you know, there won't be any need to rush. We will have it mixed, or you can mix it yourself. But, and really, we were initially going to have it all mixed, but the hospitals prefer to mix it themselves. They don't want someone else to mix it. They want to mix it themselves. So we will have both, so you'll be able to order it.
As I said, as simple as it is to deliver Jelmyto because you need a fluoroscopy, you need to have certain equipment, you're manipulating the upper tract. It's just not like that for UGN-102. So this is something, and Mark can expand on this, but 95% of what gets done is done. They do it on an ongoing basis. So they're used to giving these intravesical therapies in their office. So being able to do it, actually, we did a small home study. I don't know if you remember that.
Yeah.
A small home study, really just to demonstrate that you can give it at home. Now, you know, we don't expect much uptake at home, but it's available. So, you know, hopefully, if, you know, if a patient, you know, can't, you know, is in a situation where they can't come to the doctor's office, that they would be able to use it through a home health nurse. And we were able to demonstrate the ease of use, and that was actually the purpose of the study, was to demonstrate how easy it is to use. And so we are definitely doing everything we can to make the ease of use as, you know, as, as seamless as possible for the physician office, because, because that's very important.
Great. You know, we still haven't seen the longer term, uh, ENVISION data yet, but I do want to actually talk a little bit about lifecycle management-
Sure
... as you think about what 102 and just, you know, how do you think about advancing it into other populations, whether it's high risk, post BCG, what- whatever you think is relevant here and just sort of what are sort of clinical development plans as you're thinking about lifecycle management?
It's a great question and something we've spent a lot of time talking about. There's actually a lot of different populations where you can move UGN-102 into the high-grade space. You can do it in combination with our CTLA-4 that we've talked about. You know, one of the areas that I'm interested in is even actually the larger, lower, low-grade patient population for those unwilling or unable to go through surgery, right? We talked about the fact that the intermediate risk is only about 20% of the patient population, but you have patients in this, in the broader patient population that shouldn't be going through. There's a lot of opportunity for UGN-102. We also have our next generation formulation, you know, that we'll be launching.
You know, there's a lot of interest by physicians and by us internally, to do more with UGN-102. Mark, I don't know if I missed something there somewhere.
No, that was great. I think Liz's remarks really demonstrate or really showcase the fact that we think there's a lot of potential for other underserved populations of patients, and we'd love to work on those, and we intend to do that as we move forward.
Okay. I want to touch a little bit, Liz, on something we were talking about before the session, which is just sort of, you know, investor interest in this space has picked up-
Yes.
Just because there are some novel companies or established companies that are working in different areas of bladder cancer, that I think have sparked, you know, greater investor interest in the category versus in recent years. And so, you know, as you look at the competitive landscape, you know, Liz, whether it's a CG or a J&J, TARIS device, maybe, how do you think about the competitive landscape versus, you know, advancing life cycle management for your existing programs and maybe cutting off potential competition at the pass?
Yeah, I think ... Look, it's a great question, and you're right. I was actually, I know people think it's sort of weird, but I always say, the more the merrier, because it does bring more attention to the space. And actually, not only that, but these patients, these are not cures. Patients need more treatments, right? And bladder cancer had really been pretty much ignored by most companies up until now. If you think about other, other, tumors, you know, there's multiple lines of therapy. We need multiple lines of therapy for these patients, because, again, they need to have more treatments, particularly in high-grade disease.
Now, as we think about competition, you know, from the low-grade space, first of all, we'll be the first, you know, assuming we get approval, we'll be the first in this space, and no one will be there for a few years after us. I think you have to look at it from the data. Let's see what happens on Thursday. So I think we will be the bar that in the low- grade, intermediate risk. I think it remains to be seen what the real bar is for some of the medicines coming out today. If you look at the ones that are there, Adstiladrin , Keytruda. Look at those 12-month CR rates, they, you know, they're not similar to where, to what we have. J&J's has been better, CG's has been better, but there's still limited data out there.
So on one hand, I'm very excited about the fact that there's more energy around bladder cancer. I think it's great for patients. I think it will. You know, more companies talking about it will expand the category, will help physicians make the transition from doing surgery on everyone to using these medicines. So I'm happy to have, you know, more, more coming. I think what, what you'll see is I think we'll be the bar, and I think, you know, we have a lot of positives in our company, and we're excited about, you know, our ability to be the first medicine approved in this, patient population. And as we move into other patient populations, obviously, the bars will be different, you know, and we'll have to only bring products to market that we believe have a meaningful advance with patients.
But I think that's great. Let's continue to raise the bar.
Okay, great. Maybe one conceptual question is, you know, as you think about competition down the road, let's say in the low-grade space, do you envision competitors requiring head-to-head studies, whether it's a full approval down the road, in terms of your label, just head-to-head studies? Or do you think people just, for the time being, will benchmark against your pending data here?
Yeah, I think right now, like, if you start a study today, obviously nothing else is approved, so I think you don't-- you probably won't have to do a head-to-head study. I think a couple of years from now, if you start studies, then you'll have to, you know, when, you know, medicines are available, you'll have to have a head-to-head. You know, I think you're starting to see that in high-grade disease, right? Mostly you go after post BCG or BCG failures, and now you're going to get to the point where it's, like, after you fail two therapies, which is pretty typical in oncology, right? You start late, you come up earlier. But I do think we'll change.
I mean, right now, the FDA, you know, before, because there was nothing there, but if you're going to go into front line and high grade, you have to compare against BCG, right? You can't, you can't go, in without comparing against BCG, but I think you'll start to see that more and more in the future.
Okay, very good. We're almost up on time here, so I think we'll end it on that note. My thanks to Liz and Mark from UroGen for joining us. Thank you very much.
Thank you.
Thank you.